Suppliers and packagers for generic pharmaceutical drug: TAFENOQUINE SUCCINATE

TAFENOQUINE SUCCINATE

Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
60 Degrees Pharms	ARAKODA	tafenoquine succinate	TABLET;ORAL	210607	NDA	60 Degrees Pharmaceuticals, INC.	71475-257-01	2 BLISTER PACK in 1 CARTON (71475-257-01) / 8 TABLET, FILM COATED in 1 BLISTER PACK	2018-08-20
60 Degrees Pharms	ARAKODA	tafenoquine succinate	TABLET;ORAL	210607	NDA	60 Degrees Pharmaceuticals, INC.	71475-257-02	8 TABLET, FILM COATED in 1 BOTTLE (71475-257-02)	2018-08-20
Glaxosmithkline	KRINTAFEL	tafenoquine succinate	TABLET;ORAL	210795	NDA	GlaxoSmithKline LLC	0173-0889-39	2 TABLET, FILM COATED in 1 BOTTLE (0173-0889-39)	2019-01-22

TAFENOQUINE SUCCINATE Suppliers: Which API, Drug Product, and Contract Manufacturers Supply the Market

Last updated: May 24, 2026

Who supplies tafenoquine succinate API and where are they located?

Tafenoquine succinate sourcing is typically split across (1) API manufacture (active ingredient), (2) tablet/solid-dose drug product manufacturing, and (3) salts/formulation service providers that package tafenoquine succinate into finished dosage forms. The supplier set changes by geography, regulatory listing, and whether a counterparty needs commercial scale supply or clinical/commercial bridging batches.

Supplier types in the tafenoquine succinate supply chain

• API manufacturers: produce tafenoquine (free base) and convert to tafenoquine succinate salt form under controlled solid-state specs.
• Drug product manufacturers (CMO/CDMO): compress, blend, and coat tablets for commercial or clinical supply.
• Packagers/labelers: primary/secondary packaging and country-of-origin labeling.

Buyer due diligence checklist (for supplier qualification)

• Written control strategy for polymorph/solvate form of tafenoquine succinate.
• Particle size distribution and dissolution profile controls at API-to-tablet interface.
• Regulatory status of the facility (GMP, inspection history) for your target markets.
• Route of synthesis controls, residual solvent limits, and nitrosamine testing programs (if applicable to your jurisdiction’s frameworks).

What contract manufacturers make tafenoquine succinate tablets and finished dosage forms?

Finished-dose tafenoquine succinate supply usually comes from CDMOs with established antimalarial solid-dose manufacturing experience and capacity for tablets in commercial and multi-country distribution.

Common finished dosage form scope

• Oral solid tablets (typical commercial presentation).
• Clinical batches for Phase 2 to Phase 3 trials.
• Packaging formats aligned to target country labeling and distribution requirements.

Key technical constraints buyers screen in tablet CMOs

• Salt-form specification consistency at incoming API.
• Blend uniformity and tablet potency uniformity controls.
• Stability program coverage for tafenoquine succinate in finished tablets under ICH climatic zones.
• Analytical method transfer capability (HPLC impurity profiling for tafenoquine and degradants, dissolution methods).

Which companies supply tafenoquine succinate under GMP for regulated markets?

The regulated-market supplier list depends on (1) the country’s authorized marketing route, (2) whether the API is imported or locally manufactured, and (3) the drug product’s approval holder and its licensed manufacturing sites. To identify the exact suppliers, buyers typically rely on:

• Local regulatory registration dossiers for the marketing authorization holder and manufacturing sites.
• GMP certificate registries tied to the specific manufacturing facility address.
• Third-party verification of API and finished dosage sites used for commercial lots.

How do tafenoquine succinate supplier networks differ by geography?

Tafenoquine succinate supply is often concentrated in a small number of API sources, with broader distribution of tablet manufacturing among CDMOs and secondary packagers. Geography differences usually show up in:

• API import reliance versus local API production.
• Differences in GMP inspection outcomes by facility and time.
• Local packaging and labeling partners aligned to country-specific requirements.

Typical geography patterns

• API: centralized in fewer advanced chemistry sites.
• Tablets: distributed across multiple CMOs that can handle country-specific artwork and packaging.

What is the Orange Book status for tafenoquine succinate that affects supplier selection?

No Orange Book status can be provided here. Orange Book listings apply to FDA-approved drug products and generic review, and a definitive Orange Book entry requires exact U.S. NDA/ANDA identification. Without a confirmed FDA listing and dosage form mapping, supplier conclusions tied to Orange Book ownership, listing sponsors, or paragraph IV risk cannot be produced.

What patents or exclusivity issues constrain tafenoquine succinate supplier onboarding?

Patent and exclusivity constraints depend on:

• Whether your intended product is a branded reference, authorized generic, or a separate approved generic.
• Whether any exclusivity relates to method-of-use, formulation, or salt form.

Without the specific marketing authorization and patent estate mapping, supplier onboarding barriers cannot be stated as facts for tafenoquine succinate.

What raw-material inputs and quality attributes matter most for tafenoquine succinate suppliers?

For tafenoquine succinate, the supplier’s quality system must cover the salt-form and solid-state parameters that drive bioavailability and stability.

Core quality attributes

• Identity and assay of tafenoquine succinate.
• Solubility and dissolution alignment to the reference profile.
• Impurity profile and degradant control.
• Water content and crystal habit controls (where applicable).
• Residual solvents and reagents from the synthesis route.

Testing and documentation buyers require

• CoA and CoC for API and critical intermediates where supply chain transparency is mandated.
• Full specification set including dissolution and impurity limits.
• Stability reports for API and finished tablets.
• Change-control commitments for polymorph/grade/process adjustments.

What are the main risks in switching tafenoquine succinate suppliers?

Switching suppliers is often a high-risk activity for solid-dose drugs because variations in salt form and particle attributes can translate into dissolution and bioequivalence issues.

Material switch risks

• Solid-state form drift (polymorph/particle morphology).
• Dissolution profile changes due to particle size or milling differences.
• Impurity or residual solvent differences due to synthesis route variation.
• Stability differences that trigger reformulation or retesting.

Operational mitigations

• Side-by-side comparative analytics and dissolution.
• Pilot-scale compression trials before full commercial switch.
• Regulatory bridging strategy aligned to your jurisdiction’s variation rules.

Supplier landscape for tafenoquine succinate: how to structure competitive sourcing

A robust sourcing strategy typically uses a tiered model:

1. Primary API supplier qualified for GMP and salt-form consistency.
2. Secondary API supplier for redundancy and risk mitigation.
3. Drug product CMO with tablet stability and analytical transfer capability.
4. Packaging partners with lead time reliability.

Competitive sourcing approach

• Bid on lead times, CoA/CoC documentation completeness, and change-control terms.
• Require a defined technical transfer timeline for API-to-tablet methods.
• Align contract terms to stability and retest intervals.

Key Takeaways

• Tafenoquine succinate supply is constrained less by “number of companies” and more by GMP qualification, solid-state/salt-form control, and API-to-tablet dissolution consistency.
• Supplier onboarding should prioritize documentation, solid-state specs, and stability coverage rather than only price and capacity.
• A complete, company-by-company supplier list for tafenoquine succinate requires mapping to specific FDA/local approvals and manufacturing site addresses; those firm identifiers are not provided in the input here.

FAQs

1. Who manufactures tafenoquine succinate tablets in the EU and what facilities are used for finished-dose GMP?
2. How can a buyer verify tafenoquine succinate polymorph and salt-form consistency across API lots?
3. What documentation should be requested from tafenoquine succinate API suppliers for regulatory submissions?
4. What bridging studies are typically required when switching tafenoquine succinate API suppliers for a generic tablet?
5. Which quality tests most directly predict dissolution behavior for tafenoquine succinate tablet formulations?

References

1. FDA. Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations. (Accessed 2026-05-24). https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm
2. EMA. ICH Q6A/Q6B framework and solid-state quality expectations in marketing authorisation guidance. (Accessed 2026-05-24). https://www.ema.europa.eu/